Not provided
Not provided
Not provided
Not provided
Study was terminated early due to slow recruitment rate.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
Not provided
The purpose of this study was to evaluate the improvement in spontaneous recovery from clinical deficits at the time of an acute relapse in RR-MS participants already receiving interferon (IFN) beta 1a with D-aspartate (versus placebo) as add-on therapy.
Not provided
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-aspartate + IFN beta-1a + Methylprednisolone | Experimental | Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
|
| Placebo + IFN beta-1a + Methylprednisolone | Placebo Comparator | Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-aspartate | Dietary Supplement | D-aspartate 2660 milligram (mg) once daily in the form of oral solution for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8 | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS). | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24 | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis. It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Binaghi, Università di Cagliari,ASL 8 | Cagliari | Italy | ||||
| Ospedale Clinicizzato SS. Annunziata |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | D-aspartate + IFN Beta-1a + Methylprednisolone | Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 4, 2017 |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks. |
|
| IFN beta-1a | Biological | IFN beta-1a was administered subcutaneously at a dose of 44 microgram (mcg) three times a week for 24 weeks. |
|
| Methylprednisolone | Drug | Methylprednisolone 1000 mg was administered intravenously once daily for 5 consecutive days. |
|
| Baseline, Week 12 and 24 |
| 25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The participants is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the participant walk back the same distance. Participants may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. The data for the 25-FWT is reported for the 2 completed trials. Participant wise data was reported for this outcome. | At Week 8, 12 and 24 |
| 9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The data for the 29HPT is reported for the 2 completed trials. Participant wise data was reported for this outcome. | Week 8, 12 and 24 |
| Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | Symbol digit modalities test is to evaluate neurocognitive functions. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The participants is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the participants fills in the numbers that correspond to the symbols. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance. Participant wise data was reported for this outcome. | At Week 8, 12 and 24 |
| Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | Visual acuity is measured under low contrast conditions (10% contrast relative to the chart background) at object testing distances of 10 feets and is reported as the number of letters read correctly (ranging from 0 to 10 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. Participant wise data was reported for this outcome. | Week 8, 12 and 24 |
| Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24 | MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. | Week 8, 12 and 24 |
| Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24 | Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. | Week 8, 12 and 24 |
| Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS) | TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. | Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8 |
| Number of Treated Participants With Immune-metabolic Response of Lymphocytes | Treated participants with immune-metabolic response (glycolysis, mitochondrial respiration, fatty acids oxidation and circulating adipocytokines) of lymphocytes were to be reported. | Baseline, Week 8 and 12 |
| Chieti |
| Italy |
| Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate) | Gallarate | Italy |
| Azienda Ospedaliero Universitaria San Martino | Genova | Italy |
| Ospedale P.A.Micone | Genova | Italy |
| Ospedale San Raffaele | Milan | Italy |
| A.O.U. Federico II | Naples | Italy |
| Azienda Ospedaliera di Rilievo Nazionale A. CardarelliAzienda Ospedaliera di Rilievo Nazionale A. Cardarelli | Naples | Italy |
| Seconda Università degli Studi di Napoli | Naples | Italy |
| Azienda Ospedaliera di Padova | Padova | Italy |
| I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo | Pozzilli | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Roma | Italy |
| Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza | Roma | Italy |
| Policlinico Universitario Agostino Gemelli | Roma | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | Italy |
| Ospedale S. Paolo | Savona | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti | Torrette Di Ancona | Italy |
| FG001 | Placebo + IFN Beta-1a + Methylprednisolone | Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | D-aspartate + IFN Beta-1a + Methylprednisolone | Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
| BG001 | Placebo + IFN Beta-1a + Methylprednisolone | Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8 | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS). | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. | Posted | Count of Participants | Participants | Baseline, Week 8 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24 | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis. It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS). | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. | Posted | Count of Participants | Participants | Baseline, Week 12 and 24 |
| |||||||||||||||||||||||||||||||
| Secondary | 25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The participants is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the participant walk back the same distance. Participants may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. The data for the 25-FWT is reported for the 2 completed trials. Participant wise data was reported for this outcome. | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint. | Posted | Number | Seconds | At Week 8, 12 and 24 |
| |||||||||||||||||||||||||||||||
| Secondary | 9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The data for the 29HPT is reported for the 2 completed trials. Participant wise data was reported for this outcome. | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint. | Posted | Number | Seconds | Week 8, 12 and 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | Symbol digit modalities test is to evaluate neurocognitive functions. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The participants is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the participants fills in the numbers that correspond to the symbols. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance. Participant wise data was reported for this outcome. | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint. | Posted | Number | units on a scale | At Week 8, 12 and 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | Visual acuity is measured under low contrast conditions (10% contrast relative to the chart background) at object testing distances of 10 feets and is reported as the number of letters read correctly (ranging from 0 to 10 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. Participant wise data was reported for this outcome. | Full analysis set. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "Number of participants analyzed" signifies those who were evaluable for this endpoint and "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint. | Posted | Number | Letters read correctly | Week 8, 12 and 24 | eye | eye |
| |||||||||||||||||||||||||||||
| Secondary | Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24 | MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint. | Posted | Number | units on a scale | Week 8, 12 and 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24 | Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint. | Posted | Number | units on a scale | Week 8, 12 and 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS) | TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. | Full analysis set. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "Number of participants analyzed" signifies those who were evaluated for this endpoint and "number analyzed" signifies specific participant evaluated in respective arm. | Posted | Number | millivolts | Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Treated Participants With Immune-metabolic Response of Lymphocytes | Treated participants with immune-metabolic response (glycolysis, mitochondrial respiration, fatty acids oxidation and circulating adipocytokines) of lymphocytes were to be reported. | Data was not collected since the study was prematurely terminated, due to slow recruitment rate. | Posted | Baseline, Week 8 and 12 |
|
Baseline up to 292 days; Participants were assessed for adverse events for the entire study
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-aspartate + IFN Beta-1a + Methylprednisolone | Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG001 | Placebo + IFN Beta-1a + Methylprednisolone | Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. | 0 | 2 | 0 | 2 | 2 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersexuality | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Flu-like symptoms | Infections and infestations | Non-systematic Assessment |
| ||
| Weight gain | General disorders | Non-systematic Assessment |
| ||
| Pain in the left thigh | General disorders | Non-systematic Assessment |
| ||
| Periorbital pain | Eye disorders | Non-systematic Assessment |
|
Study was prematurely terminated, due to slow recruitment rate.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Jan 10, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026603 | D-Aspartic Acid |
| C428112 | peginterferon beta-1a |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D001224 | Aspartic Acid |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
|
|
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
|
|
| Placebo + IFN Beta-1a + Methylprednisolone |
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
|
|
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|
|
|
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
|
|
| OG001 | Placebo + IFN Beta-1a + Methylprednisolone | Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. |
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